Abstract Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey Department of Health and Senior Services - Division of HIV/AIDS Services, NJHIV operates one of the largest, centralized rapid HIV test programs in the country. Integral to the program is a comprehensive quality assurance program. Of paramount importance to the program is the accuracy of the each site’s data. Due to reports of increased false-positive test results in San Francisco and New York, we assessed the accuracy of NJHIV testing data in order to reliably review OraQuick performance in New Jersey. Objective: Implementation of a self- evaluation methodology able to validate data and to verify that OraQuick testing is performs within specifications in New Jersey. Methods: NJHIV sites maintain logs of each test performed, with monthly reviews by RWJMS. Data is consolidated via Excel spreadsheets and passed into a rapid HIV database. Scheduled and unscheduled audits of client records are coupled with re-education of staff at client sites, as needed. Audit results were compared with the NJHIV database and two State databases, and corrected by referring back to client files. Data was examined by month, site, reagent lot, sample type and test result. Results: Data from 22 of 23 sites was complete in the NJHIV database. For one site, comparable defects were found in all databases. After remediation of recordkeeping, data from that site is now also complete. The analysis showed specificity in the NJHIV program of 99.6%--within the manufacturer’s specifications. The increased false- positive results that was reported in other jurisdictions has not occurred within the quality assurance framework of the NJHIV program. Conclusion: Data monitoring at the NJHIV program allows for detailed examination of patterns of test results. Practices at the NJ HIV Rapid Testing Program are generating accurate results which fall within acceptable specificity limits. Results FALSE POSITIVE RATES IN NEW JERSEY Fifteen sites have been identified as high volume and prevalence sites. Fourteen more have been identified as second tier in importance based on prevalence and volume. The remaining 129 satellite sites are of lower priority based on prevalence and testing volume and will be implemented as resources permit. RETURN FOR RESULTS: Through July 2004, 3062 people had HIV rapid testing, 3053 of whom (99.7%) received their results and had posttest counseling. Out of the 110 confirmed positive results, 69 (63%) were previously undiagnosed patients. QUALITY CONTROL (QC) RESULTS: Sites run QC for a variety of reasons. During 2003-4, 19.5% (1925) of devices were used to perform QC. The majority of QC was run as a part of mandated operating procedures. Approximately 6% of QC was run because of ‘Out of Temperature Range’ findings at monitored storage locations. Mandatory QC due to an invalid result was extremely rare. FALSE POSITIVE RATE: The false positive rate was 4.05/10,000. All false positive were Type I discordants i.e., reproducible, OraQuick ® Positive, EIA/Western Blot negative. No examples of Type II discordants – evolving infections in a window period. Conclusion In New Jersey, the ability to start rapid-testing is limited by licensure process and quality assurance requirements By use of a standardized, ANALYSIS OF FALSE POSITIVE RAPID HIV TESTS ANALYSIS OF FALSE POSITIVE RAPID HIV TESTS , Evan M Cadoff 1 , MD, Sindy M Paul, MD, MPH 2 , Eugene G Martin, PhD 1 , Vivian Shih 1 , Gratian Salaru, MD 1 UMDNJ – Robert Wood Johnson Medical School 1 and New Jersey Department of Health and Human Services 2 Background • Built upon existing UMDNJ-Robert Wood Johnson Medical School, multi-facility, point-of- care-testing program • Centralized quality assurance process using pathologists, technologists and informaticians • A single site in New Brunswick, NJ was used to delineate process develop strategy, validate forms, communications, equipment and techniques. • Testing began November 2003 at the first NJ licensed site – a primary site in close proximity to the medical school. Currently there are 117 sites including fixed and mobile venues • Testing activities are reviewed monthly by a medical technologist Quality Assurance Plan • Management by a board certified Pathologist • Supervisory control through site coordinators • Central lab overseesr: • Regulatory and proficiency testing • Acquisition and validation of supplies • Inventory control • Common procedures and core policies • Uniform administration at all locations • Common training, certification of personnel, forms • Core communication hub www.njhiv.org • Quality Control Rules • Standardized monthly site visits – ‘The Report Card’ • Intra and inter site comparisons to insure that requirements for quality and process control are maintained Quality Assurance Issues Encountered: • Temperature Issues • Reagent Storage • Storage of Controls • Testing Environment • Reading of Devices • Under vs. Over Ascertainment • Documentation • Availability of procedures • Supervisory Oversight • Availability of Technical Support H IV Testing atC TS sites in N J 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% Year Prevalence 0 5000 10000 15000 20000 25000 30000 35000 Utilization Prevalence Utilization AIDS Coalition of Southern New Jersey Atlantic City Health Department Bergen County Health Department Burlington County Health Department Camden AHEC Camden County Health Department East Orange Health Department Eric B. Chandler Health Center FamCare Henry J. Austin Health Center Horizon Health Center Hunterdon County Health Department Hyacinth Foundation Martin Luther King Outreach Morristown Memorial Hospital Newark Community Health Center NJCRI Ocean County Health Department Paterson Health Department Plainfield Community Health Center Proceed Robert Wood Johnson Medical School Trinitas Hospital UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES Primary Satellite fixed mobile Pale colors indicate pending sites 0 200 400 600 800 1000 1200 1400 1600 N um beroftests June July Aug Sept O ct N ov M onth (2005) R apid H IV tests B lood O ral
Abstract Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey.
Jan 15, 2016
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Abstract
Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey Department of Health and Senior Services - Division of HIV/AIDS Services, NJHIV operates one of the largest, centralized rapid HIV test programs in the country. Integral to the program is a comprehensive quality assurance program. Of paramount importance to the program is the accuracy of the each site’s data. Due to reports of increased false-positive test results in San Francisco and New York, we assessed the accuracy of NJHIV testing data in order to reliably review OraQuick performance in New Jersey.
Objective: Implementation of a self-evaluation methodology able to validate data and to verify that OraQuick testing is performs within specifications in New Jersey.
Methods: NJHIV sites maintain logs of each test performed, with monthly reviews by RWJMS. Data is consolidated via Excel spreadsheets and passed into a rapid HIV database. Scheduled and unscheduled audits of client records are coupled with re-education of staff at client sites, as needed. Audit results were compared with the NJHIV database and two State databases, and corrected by referring back to client files. Data was examined by month, site, reagent lot, sample type and test result.
Results: Data from 22 of 23 sites was complete in the NJHIV database. For one site, comparable defects were found in all databases. After remediation of recordkeeping, data from that site is now also complete. The analysis showed specificity in the NJHIV program of 99.6%--within the manufacturer’s specifications. The increased false-positive results that was reported in other jurisdictions has not occurred within the quality assurance framework of the NJHIV program.
Conclusion: Data monitoring at the NJHIV program allows for detailed examination of patterns of test results. Practices at the NJ HIV Rapid Testing Program are generating accurate results which fall within acceptable specificity limits.
ResultsFALSE POSITIVE RATES IN NEW JERSEY
Fifteen sites have been identified as high volume and prevalence sites. Fourteen more have been identified as second tier in importance based on prevalence and volume. The remaining 129 satellite sites are of lower priority based on prevalence and testing volume and will be implemented as resources permit.
RETURN FOR RESULTS:
Through July 2004, 3062 people had HIV rapid testing, 3053 of whom (99.7%) received their results and had posttest counseling.
Out of the 110 confirmed positive results, 69 (63%) were previously undiagnosed patients.
QUALITY CONTROL (QC) RESULTS:
Sites run QC for a variety of reasons. During 2003-4, 19.5% (1925) of devices were used to perform QC. The majority of QC was run as a part of mandated operating procedures. Approximately 6% of QC was run because of ‘Out of Temperature Range’ findings at monitored storage locations. Mandatory QC due to an invalid result was extremely rare.
FALSE POSITIVE RATE:
The false positive rate was 4.05/10,000. All false positive were Type I discordants i.e., reproducible, OraQuick® Positive, EIA/Western Blot negative. No examples of Type II discordants – evolving infections in a window period.
Conclusion In New Jersey, the ability to start rapid-testing is limited by licensure process and quality assurance requirements By use of a standardized, centralized approach rapid testing has been implemented in an efficient, cost-effective and quality-focused processLow false-positive rates in New Jersey may be due to currently employed methodology and aggressive quality assurance oversight
ANALYSIS OF FALSE POSITIVE RAPID HIV TESTSANALYSIS OF FALSE POSITIVE RAPID HIV TESTS
Jake Nelson1, Evan M Cadoff1 , MD, Sindy M Paul, MD, MPH2, Eugene G Martin, PhD1, Vivian Shih1, Gratian Salaru, MD1
UMDNJ – Robert Wood Johnson Medical School1 andNew Jersey Department of Health and Human Services 2
Background• Built upon existing UMDNJ-Robert Wood Johnson
Medical School, multi-facility, point-of-care-testing program
• Centralized quality assurance process using pathologists, technologists and informaticians
• A single site in New Brunswick, NJ was used to delineate process develop strategy, validate forms, communications, equipment and techniques.
• Testing began November 2003 at the first NJ licensed site – a primary site in close proximity to the medical school. Currently there are 117 sites including fixed and mobile venues
• Testing activities are reviewed monthly by a medical technologist
Quality Assurance Plan• Management by a board certified Pathologist• Supervisory control through site coordinators• Central lab overseesr:
• Regulatory and proficiency testing • Acquisition and validation of supplies • Inventory control • Common procedures and core policies• Uniform administration at all locations • Common training, certification of personnel, forms • Core communication hub www.njhiv.org
• Quality Control Rules • Standardized monthly site visits – ‘The Report Card’
• Intra and inter site comparisons to insure that requirements for quality and process control are maintained
Quality Assurance Issues Encountered:
• Temperature Issues• Reagent Storage • Storage of Controls • Testing Environment
• Reading of Devices • Under vs. Over Ascertainment• Documentation
• Availability of procedures• Supervisory Oversight• Availability of Technical Support
HIV Testing at CTS sites in NJ
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
Year
Pre
vale
nce
0
500010000
15000
20000
2500030000
35000
Uti
lizat
ion
Prevalence
Utilization
QC Usage - Year OneCtrl 1 First Day of the WeekCtrl 2 Temperature Out of RangeCtrl 3 Annonymous TestingCtrl 4 New ShipmentCtrl 5 Invalid ResultCtrl 6 QC FailureCtrl 7 Coordinator AssignedCtrl 8 - Other
AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital
UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES Primary Satellite fixed mobile Pale colors indicate pending sites
0
200
400
600
800
1000
1200
1400
1600
Nu
mb
er
of
tes
ts
June July Aug Sept Oct Nov
Month (2005)
Rapid HIV tests
Blood
Oral
ABSTRACT
Background: Directed by the Department of Pathology and Laboratory Medicine at Robert Wood Johnson Medical School (RWJMS), and funded by New Jersey Department of Health and Senior Services - Division of HIV/AIDS Services, NJHIV operates one of the largest, centralized rapid HIV test programs in the country. Integral to the program is a comprehensive quality assurance program. Of paramount importance to the program is the accuracy of the each site’s data. Due to reports of increased false-positive test results in San Francisco and New York, we assessed the accuracy of NJHIV testing data in order to reliably review OraQuick performance in New Jersey.
Objective: Implementation of a self-evaluation methodology able to validate data and to verify that OraQuick testing is performs within specifications in New Jersey.
Methods: NJHIV sites maintain logs of each test performed, with monthly reviews by RWJMS. Data is consolidated via Excel spreadsheets and passed into a rapid HIV database. Scheduled and unscheduled audits of client records are coupled with re-education of staff at client sites, as needed. Audit results were compared with the NJHIV database and two State databases, and corrected by referring back to client files. Data was examined by month, site, reagent lot, sample type and test result.
Results: Data from 22 of 23 sites was complete in the NJHIV database. For one site, comparable defects were found in all databases. After remediation of recordkeeping, data from that site is now also complete. The analysis showed specificity in the NJHIV program of 99.6%--within the manufacturer’s specifications. The increased false-positive results that was reported in other jurisdictions has not occurred within the quality assurance framework of the NJHIV program.
Conclusion: Data monitoring at the NJHIV program allows for detailed examination of patterns of test results. Practices at the NJ HIV Rapid Testing Program are generating accurate results which fall within acceptable specificity limits.
AIDS Coalition of Southern New JerseyAtlantic City Health DepartmentBergen County Health DepartmentBurlington County Health DepartmentCamden AHECCamden County Health DepartmentEast Orange Health DepartmentEric B. Chandler Health CenterFamCareHenry J. Austin Health CenterHorizon Health CenterHunterdon County Health DepartmentHyacinth FoundationMartin Luther King OutreachMorristown Memorial HospitalNewark Community Health CenterNJCRIOcean County Health DepartmentPaterson Health DepartmentPlainfield Community Health CenterProceedRobert Wood Johnson Medical SchoolTrinitas Hospital
04/21/23
UMDNJ-RWJMS/ NJ DHSS AIDS PREVENTION GRANTEES Primary Satellite fixed mobile Pale colors indicate pending sites
S.F. Clinics getting high false-positive rate on oral hiv test
Sabin Russell
San Francisco Chronicle
Friday, December 9, 2005
“A promising new oral hiv test being considered for home use has produced at least 47 false positives at san Francisco public health clinics, throwing a scare into those who received the results and raising questions about the test's suitability for widespread use in the united states and abroad.
The oraquick advance hiv test approved for professional use by the food and drug administration in
March 2004 detects in just 20 minutes antibodies to the virus that causes aids, using fluid swabbed from the m Mouth.
Its speed and ease of use make the test a particularly suitable candidate for hiv prevention and treatment
Efforts that stress frequent testing and speedy access to care for those who test positive.
San francisco department of public health officials were alarmed last week when their analyses of more
Than 6,000 oral tests since spring turned up 47 instances in which the results were positive, but follow-up tests
Showed those patients were not infected.”
QC Usage - Year One
35%
6%35%
10%0%0%4% 10%
Ctrl 1 First Day of the Week Ctrl 2 Temperature Out of Range
Ctrl 3 Annonymous Testing Ctrl 4 New Shipment
Ctrl 5 Invalid Result Ctrl 6 QC Failure
Ctrl 7 Coordinator Assigned Ctrl 8 - Other
QC Usage - Year One
35%
6%35%
10%0%0%4% 10%
Ctrl 1 First Day of the Week Ctrl 2 Temperature Out of Range
Ctrl 3 Annonymous Testing Ctrl 4 New Shipment
Ctrl 5 Invalid Result Ctrl 6 QC Failure
Ctrl 7 Coordinator Assigned Ctrl 8 - Other
Quality Assurance Plan• Management by a board certified Pathologist• Supervisory control through site coordinators• Central lab overseesr:
• Regulatory and proficiency testing • Acquisition and validation of supplies • Inventory control • Common procedures and core policies• Uniform administration at all locations • Common training, certification of personnel,
forms • Core communication hub www.njhiv.org
• Quality Control Rules • Standardized monthly site visits – ‘The Report
Card’• Intra and inter site comparisons to insure that
requirements for quality and process control are maintained
Quality Assurance Issues Encountered:
• Temperature Issues• Reagent Storage • Storage of Controls • Testing Environment
• Reading of Devices • Under vs. Over Ascertainment• Documentation
• Availability of procedures• Supervisory Oversight• Availability of Technical Support
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